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NCT03207555 · ClinicalTrials.gov registry record · Phase 2

Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT03207555: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT03207555 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03207555, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given. The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop. This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop. The study doctor can describe how the study drug is designed to work. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Primary Outcome

Complete Remission (CR): Peripheral blood lymphocytes below 4 x 10\^9/L (4000/ƒÝL), Absence of significant lymphadenopathy (lymph nodes \>1.5 cm in diameter) by CT(or PET) examination of neck, thorax, abdomen and pelvis, No hepatomegaly or splenomegaly by physical examination (and CT/PET if assessment was abnormal before therapy or if physical exam is inconclusive), Absence of constitutional symptoms, Neutrophils more than 1.5 x 10\^9/L (1500/ƒÝL) without need for exogenous growth factors, Plate

Interventions

  • DRUG Ibrutinib

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2018-05-23
Est. Completion 2024-08-02
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT03207555 record still lists

NCT03207555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Ibrutinib is the first listed.

NCT03207555 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03207555 about?

NCT03207555 is a clinical study titled "Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)". The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given. The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who d...

What is the current status of trial NCT03207555?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-05-23. Estimated completion is 2024-08-02.

What interventions are being tested in trial NCT03207555?

The interventions under investigation include: Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT03207555?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03207555's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03207555, the US trial registry maintained by the National Library of Medicine. NCT03207555 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.